NCT05306730

Brief Summary

The aim of the study is to find out the benefit of echocardiography, which is performed by a physican without a cardiological or radiological specialty. In this case the echocardiography is used in the first contact with a patient with chest pain of unclear etiology. Possible benefit is rapid risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

February 14, 2022

Last Update Submit

March 22, 2022

Conditions

CardiologyAcute Coronary SyndromeEchocardiography

Keywords

EchocardiographyPoint-of-care ultrasound

Outcome Measures

Primary Outcomes (1)

  • Time of patient stay at Emergency Department

    Time from initial contact with patient to patient discharge or hospital admission (minutes)

    24 hours

Secondary Outcomes (2)

  • Time of stay at hospital

    28 days

  • Major adverse cardiovascular events

    30 days

Other Outcomes (2)

  • Time to Coronary Angiography

    365 days

  • Accuracy of thoracic ultrasound exam provided by non-cardiologist

    30 days

Study Arms (2)

FOCUS group

EXPERIMENTAL

Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.

Device: ECHOcardiography, Point-of-Care UZ

Non-FOCUS group

ACTIVE COMPARATOR

Patients with even registration number.

Device: ECHOcardiography, Point-of-Care UZ

Interventions

ECHOcardiography, Point-of-Care UZDEVICE

Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection. The aim of interest is to consider riscs and benefits of the ultrasound of heart done by non-cardiologist after standardized course.

FOCUS groupNon-FOCUS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
  • Higher age than 18

You may not qualify if:

  • STEMI
  • Pacemaker / ICD
  • Pregnancy
  • Performance status 4 ( Zubrod scale )
  • Informed Consent unsigned
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Grenar P, Jakl M, Medilek K, Novy J, Koci J, Vanek J, Cermakova M, Horacek JM, Pudil R. Effect of point-of-care echocardiography by noncardiologists on patient management in acute chest pain. Intern Emerg Med. 2025 Nov 24. doi: 10.1007/s11739-025-04198-6. Online ahead of print.

    PMID: 41284127DERIVED

  • Grenar P, Novy J, Medilek K, Jakl M. Point-of-Care Cardiac Ultrasound Training Programme: Experience from the University Hospital Hradec Kralove. Emerg Med Int. 2024 Jan 6;2024:9974284. doi: 10.1155/2024/9974284. eCollection 2024.

    PMID: 38222095DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Martin Jakl, assoc.prof.

    University of Defense, Faculty of Military Health Sciences, Czech Republic

    STUDY DIRECTOR

  • Petr Grenar, MD

    University of Defense, Faculty of Military Health Sciences, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Grenar, MD

CONTACT

+420724027318petr.grenar@fnhk.cz

Martin Jakl, assoc.prof.

CONTACT

+420607514962martin.jakl@fnhk.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

April 1, 2022

Study Start

May 1, 2022

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

To be shared: * baseline characteristics of study population * data related to primary and secondary endpoints

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Available 1 year after completing the study, for at least 10 years
Access Criteria
Contact principal investigator